Quality Assurance Manager, Finished Goods

The Quality Assurance professional will serve as the primary QA representative for commercial finished goods and external manufacturing partners. This role is responsible for overseeing quality activities related to finished goods packaging, labeling, and serialization to support global product distribution. The position requires hands-on experience with finished goods and strong collaboration with cross-functional and external teams.

Key Responsibilities

• Serve as QA representative for commercial finished goods and external manufacturing partners
• Oversee quality aspects of finished goods, including:
• Specifications
• Qualification and validation activities
• Drawings, artwork, labels, serialization, and packaging operations
• Review and approve manufacturing partner documentation, including:
• Bills of Materials (BOMs)
• Manufacturing and Packaging Records (MPRs)
• Product specifications and variable data
• Ensure proper archival and maintenance of manufacturing partner documentation within electronic quality systems
• Manage and approve quality records such as deviations, CAPAs, change controls, and issue escalations
• Lead and support investigations, root cause analysis, and implementation of corrective and preventive actions
• Identify and recommend continuous improvement opportunities to reduce current and future quality risks
• Collaborate effectively with internal stakeholders and external manufacturing partners

Qualifications & Experience

• Bachelor’s degree in Life Sciences, Engineering, or a related field
• Minimum of 5 years of experience in:
• Finished goods packaging and labeling
• QA oversight of external manufacturing partners
• Direct experience supporting commercial finished goods operations
• Strong organizational, interpersonal, and communication skills
• Proven experience leading investigations and implementing corrective actions
• Proficiency with electronic quality systems (e.g., Veeva or similar platforms)

• Contract position, 40 hours per week
• Hybrid schedule: 2 days onsite
• Minimal travel to manufacturing sites as needed